By Sneha S K
Oct 28 (Reuters) – The US health department said on Wednesday it will temporarily allow licensed pharmacies and physicians to compound certain unapproved peptide ingredients, while regulators decide whether to formally permit their use in compounded medicines.
The interim policy, published in the Federal Register, covers six peptides, including popular tissue-repair compound BPC-157 and TB-500 — often taken together in a combination popularly known as the “Wolverine stack”.
The others are epitalon for insomnia, KPV for wound healing and inflammatory conditions, MOTS-c for obesity and osteoporosis, and Semax for migraines and chronic pain.
The decision follows a recommendation from an FDA advisory committee to allow all six peptides in compounding. Several panel members had ties to peptide-selling businesses or clinics, but the Department of Health and Human Services said all cleared standard ethics checks.
Compounded drugs are not FDA-approved, meaning the agency does not review their safety, effectiveness or quality before they are marketed.
Peptides, or short chains of amino acids, have boomed in popularity over the past year, driven by endorsements from wellness influencers, for uses ranging from anti-aging to muscle recovery and tissue repair.
The HHS said it would not take enforcement action against compounders using certain peptide ingredients if they meet requirements on ingredient quality, manufacturing standards, safety reporting, labeling and patient-specific prescriptions.
REGULATORY CLARITY
This policy will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients, and improve patient access, HHS said.
Lee Rosebush, chair of the American Academy of Peptide Medicine, described the policy as a “landmark regulatory milestone”, and said it cleared the path for both clinical innovation and expanded access to peptide medicine.
HHS said it may reconsider the interim policy if safety signals or product-quality problems emerge. The policy does not constitute FDA approval of the peptides or the compounded medicines made from them.
The policy could amplify tension between federal and state regulators, said Jeff Cohen, co-founder of the American Peptide Association, adding that states may not follow the federal move to relax rules.
Health Secretary Robert F. Kennedy Jr. has publicly supported broader access to peptides, calling himself a “big fan” of the treatments.
Analysts estimate the peptide industry could quickly become a $2 billion to $3 billion market if legitimized.
Telehealth companies such as Hims & Hers Health have been preparing to roll out peptide offerings once cleared by federal regulators.
(Reporting by Sneha S K and Kamal Choudhury in Bengaluru; Editing by Shilpi Majumdar, Maju Samuel and Vijay Kishore)
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